CLEXANE 80MG/0.8ML SYRINGES
Active substance(s): ENOXAPARIN SODIUM / SODIUM ENOXAPARIN
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PACKAGE LEAFLET: INFORMATION FOR THE USER
Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes).
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again
■ If you have any further questions, ask your doctor or pharmacist
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
■ If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger. This helps your body to break
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
■ Treat blood clots that are in your blood
■ Stop blood clots forming in your blood in the following situations:
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
■ After you have had a heart attack
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor, pharmacist or nurse if:
■
■
■
■
■
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You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
or dalteparin
You have a problem with bruising or bleeding too easily
You have an ulcer in your stomach or gut (intestine)
You have had a stroke caused by bleeding in the brain
You have an infection in your heart
You are using the medicine called heparin to treat blood clots
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before using this medicine if:
■
■
■
■
■
■
■
■
■
■
■
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your eyes or brain
You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and especially if you are aged over 75 years old
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or
nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Clexane can affect the way some other medicines work. Also
some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
■ You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following medicines:
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming
■ Dextran injection - used as a blood replacer
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in
arthritis and other illnesses
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid
arthritis and other conditions
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane
Your doctor may change one of your medicines or take regular blood tests to check that
taking these medicines with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
have any problem with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as
you may be at increased risk of developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
3. How to use Clexane
Having this medicine
■
■
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■
Before you use Clexane your doctor or nurse may carry out a blood test
While you are in hospital your doctor or nurse will normally give you Clexane. This is
because it needs to be given as an injection
When you go home you may need to continue to use Clexane and give it to yourself
(see below instructions on how to do this)
Clexane is usually given by injection underneath the skin (subcutaneous)
If you are not sure why you are receiving Clexane or have any questions about how much
Clexane is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
■
■
Your doctor will decide how much to give you. The amount of Clexane given to you will
depend on the reason it is being used
If you have problems with your kidneys, you may be given a smaller amount of Clexane
1) Treating blood clots that are in your blood
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the following situations:
a) Unstable angina
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
b) After an operation or long periods of bedrest due to illness
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
are to develop a clot
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
each day. If you are going to have an operation, your first injection will usually be
given 2 hours before your operation
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
going to have an operation, your first injection will usually be given 12 hours before
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ At the same time, you will also be given Clexane as an injection under your skin
(subcutaneous injection). The usual dose is 1mg for every kilogram of your weight.
■ Then you will be given 1mg for every kilogram of your weight every 12 hours after
that
■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
If you are aged 75 years or older
■ Your doctor or nurse will give you injections of Clexane under your skin
(subcutaneous injection)
■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
■ The maximum amount of Clexane given for the first two injections is 75mg
For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ Depending on when you were last given Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
3) Stop blood clots forming in the tubes of your dialysis machine
■ The usual dose is 1 mg for every kilogram of your weight
■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
session
■ This amount is usually enough for a 4 hour session. However, your doctor may give
you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not been trained how to do so. If you are not
sure what to do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
■
■
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■
■
Check the expiry date on the medicine. Do not use if the date has passed
Check the syringe is not damaged and the medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are going to inject
Check your abdomen to see if the last injection caused any redness, change in skin
colour, swelling, oozing or is still painful, if so talk to your doctor or nurse
Decide where you are going to inject the medicine. Change the place where you inject
each time from the right to the left side of your stomach. Clexane should be injected just
under the skin on your stomach, but not too near the belly button or any scar tissue (at
least 5 cm away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with soap and water. Dry them.
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
Blood Tests
Using Clexane may affect the results of some blood tests. If you are going to have a blood
test, it is important to tell your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away if you notice any of the
following side-effects:
Very common (affects more than 1 in 10 people)
■ Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
■ A painful rash of dark red spots under the skin which do not go away when you put
pressure on them. You may also notice pink patches on your skin. These are more likely
to appear in the area you have been injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
■ Sudden severe headache. This could be a sign of bleeding in the brain.
■ A feeling of tenderness and swelling in your stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
■ If you have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
■ If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the lower part of your body. Also if you lose
control over your bladder or bowel (so you cannot control when you go to the toilet).
3) Choose an area on the right or left side of your stomach. This should be at least 5
centimetres away from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres of your belly button or around
existing scars or bruises. Change the place where you inject between the left and right
sides of your stomach, depending on the area you were last injected.
4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch
anything. This is to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and with your other hand,
gently pinch the cleaned area of your abdomen between your forefinger and thumb to
make a fold in the skin.
Tell a nurse or doctor as soon as possible if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
(thrombocytopenia).
■ You have pain, swelling or irritation in the area you have been injected with Clexane.
This normally gets better after a few days.
Rare (affects less than 1 in a 1000 people)
■ If you have a mechanical heart valve, treatment with Clexane might not be sufficient to
prevent blood clots. You may notice that you have difficulty breathing, tiredness or
difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This
could be due to a blood clot on the heart valve
Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Very common (affects more than 1 in 10 people)
■ Changes in the results of blood tests done to check how your liver is working. These
usually go back to normal after you stop having Clexane.
Rare (affects less than 1 in a 1000 people)
■ Changes in the potassium levels in your blood. This is more likely to happen in people
with kidney problems or diabetes. Your doctor will be able to check this by carrying out a
blood test.
Frequency unknown
■ If Clexane is used for a long period of time, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break
Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Insert the full length of the needle into the skin fold.
7) Press down on the plunger with your finger.
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date, which is stated on the carton.
Do not store above 25°C. Do not refrigerate or freeze.
If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. If you are using
this medicine at home you will be given a container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to protect the environment.
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8) Remove the needle by pulling it straight out.
You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself.
6. Further Information
9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the
container lid tightly and place the container out of reach of children.
When the container is full, give it to your doctor or home care nurse for disposal.
Do not put it in the household rubbish.
■
If you have more Clexane than you should
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no signs of a problem. If a child accidentally
injects or swallows Clexane, take them to a hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as you remember. Do not give
yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary
will help to make sure you do not miss a dose.
If you stop using Clexane
It is important for you to keep having Clexane injections until your doctor decides to stop
them. If you stop, you could get a blood clot which can be very dangerous.
What Clexane contains
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Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.4ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 1ml
The other ingredient is water for injections
active
active
active
active
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
POM
PL No: 15814/1002
The Manufacturer is Sanofi Winthrop Industrie, Boulevard Industrial, Le Trait, F-76580
France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet revision and issue date (Ref.) 09.09.2013.
The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes).
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again
■ If you have any further questions, ask your doctor or pharmacist
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
■ If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger. This helps your body to break
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
■ Treat blood clots that are in your blood
■ Stop blood clots forming in your blood in the following situations:
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
■ After you have had a heart attack
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor, pharmacist or nurse if:
■
■
■
■
■
■
■
You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
or dalteparin
You have a problem with bruising or bleeding too easily
You have an ulcer in your stomach or gut (intestine)
You have had a stroke caused by bleeding in the brain
You have an infection in your heart
You are using the medicine called heparin to treat blood clots
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before using this medicine if:
■
■
■
■
■
■
■
■
■
■
■
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your eyes or brain
You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and especially if you are aged over 75 years old
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or
nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Clexane can affect the way some other medicines work. Also
some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
■ You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following medicines:
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming
■ Dextran injection - used as a blood replacer
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in
arthritis and other illnesses
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid
arthritis and other conditions
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane
Your doctor may change one of your medicines or take regular blood tests to check that
taking these medicines with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
have any problem with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as
you may be at increased risk of developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
3. How to use Clexane
Having this medicine
■
■
■
■
Before you use Clexane your doctor or nurse may carry out a blood test
While you are in hospital your doctor or nurse will normally give you Clexane. This is
because it needs to be given as an injection
When you go home you may need to continue to use Clexane and give it to yourself
(see below instructions on how to do this)
Clexane is usually given by injection underneath the skin (subcutaneous)
If you are not sure why you are receiving Clexane or have any questions about how much
Clexane is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
■
■
Your doctor will decide how much to give you. The amount of Clexane given to you will
depend on the reason it is being used
If you have problems with your kidneys, you may be given a smaller amount of Clexane
1) Treating blood clots that are in your blood
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the following situations:
a) Unstable angina
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
b) After an operation or long periods of bedrest due to illness
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
are to develop a clot
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
each day. If you are going to have an operation, your first injection will usually be
given 2 hours before your operation
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
going to have an operation, your first injection will usually be given 12 hours before
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ At the same time, you will also be given Clexane as an injection under your skin
(subcutaneous injection). The usual dose is 1mg for every kilogram of your weight.
■ Then you will be given 1mg for every kilogram of your weight every 12 hours after
that
■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
If you are aged 75 years or older
■ Your doctor or nurse will give you injections of Clexane under your skin
(subcutaneous injection)
■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
■ The maximum amount of Clexane given for the first two injections is 75mg
For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ Depending on when you were last given Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
3) Stop blood clots forming in the tubes of your dialysis machine
■ The usual dose is 1 mg for every kilogram of your weight
■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
session
■ This amount is usually enough for a 4 hour session. However, your doctor may give
you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not been trained how to do so. If you are not
sure what to do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
■
■
■
■
■
Check the expiry date on the medicine. Do not use if the date has passed
Check the syringe is not damaged and the medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are going to inject
Check your abdomen to see if the last injection caused any redness, change in skin
colour, swelling, oozing or is still painful, if so talk to your doctor or nurse
Decide where you are going to inject the medicine. Change the place where you inject
each time from the right to the left side of your stomach. Clexane should be injected just
under the skin on your stomach, but not too near the belly button or any scar tissue (at
least 5 cm away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with soap and water. Dry them.
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
Blood Tests
Using Clexane may affect the results of some blood tests. If you are going to have a blood
test, it is important to tell your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away if you notice any of the
following side-effects:
Very common (affects more than 1 in 10 people)
■ Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
■ A painful rash of dark red spots under the skin which do not go away when you put
pressure on them. You may also notice pink patches on your skin. These are more likely
to appear in the area you have been injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
■ Sudden severe headache. This could be a sign of bleeding in the brain.
■ A feeling of tenderness and swelling in your stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
■ If you have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
■ If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the lower part of your body. Also if you lose
control over your bladder or bowel (so you cannot control when you go to the toilet).
3) Choose an area on the right or left side of your stomach. This should be at least 5
centimetres away from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres of your belly button or around
existing scars or bruises. Change the place where you inject between the left and right
sides of your stomach, depending on the area you were last injected.
4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch
anything. This is to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and with your other hand,
gently pinch the cleaned area of your abdomen between your forefinger and thumb to
make a fold in the skin.
Tell a nurse or doctor as soon as possible if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
(thrombocytopenia).
■ You have pain, swelling or irritation in the area you have been injected with Clexane.
This normally gets better after a few days.
Rare (affects less than 1 in a 1000 people)
■ If you have a mechanical heart valve, treatment with Clexane might not be sufficient to
prevent blood clots. You may notice that you have difficulty breathing, tiredness or
difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This
could be due to a blood clot on the heart valve
Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Very common (affects more than 1 in 10 people)
■ Changes in the results of blood tests done to check how your liver is working. These
usually go back to normal after you stop having Clexane.
Rare (affects less than 1 in a 1000 people)
■ Changes in the potassium levels in your blood. This is more likely to happen in people
with kidney problems or diabetes. Your doctor will be able to check this by carrying out a
blood test.
Frequency unknown
■ If Clexane is used for a long period of time, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break
Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Insert the full length of the needle into the skin fold.
7) Press down on the plunger with your finger.
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date, which is stated on the carton.
Do not store above 25°C. Do not refrigerate or freeze.
If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. If you are using
this medicine at home you will be given a container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to protect the environment.
■
■
■
■
8) Remove the needle by pulling it straight out.
You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself.
6. Further Information
9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the
container lid tightly and place the container out of reach of children.
When the container is full, give it to your doctor or home care nurse for disposal.
Do not put it in the household rubbish.
■
If you have more Clexane than you should
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no signs of a problem. If a child accidentally
injects or swallows Clexane, take them to a hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as you remember. Do not give
yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary
will help to make sure you do not miss a dose.
If you stop using Clexane
It is important for you to keep having Clexane injections until your doctor decides to stop
them. If you stop, you could get a blood clot which can be very dangerous.
What Clexane contains
■
■
■
■
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.4ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 1ml
The other ingredient is water for injections
active
active
active
active
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
POM
PL No: 15814/1002
The Manufacturer is Aventis Pharma Le Trait, Boulevard Industrial, Le Trait, F-76580
France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet revision and issue date (Ref.) 09.09.2013.
The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY
®
®
Clexane 20mg/0.2ml Syringes/ Clexane 40mg/0.4ml Syringes
Clexane® 60mg/0.6ml Syringes/ Clexane® 80mg/0.8ml Syringes
Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1. NAME OF THE MEDICINAL PRODUCT
This product is available using any of the above names but will be referred to as Clexane
throughout the following leaflet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.4ml
Each 60mg pre-filled syringe contains 60mg (6000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.6ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 1ml
the active
the active
the active
the active
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight
Kg
Syringe label
Dose (mg)
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
105 bd
110 bd
115 bd
120 bd
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg
SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two
doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients
≥75 years of age, see section 4.2 Posology and method of administration: Elderly.
the active
For full list of excipients, see section 6.1
Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
40 bd
45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended
dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the
risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose
should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as
in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous
injection with the initial dose administered approximately 12 hours before surgery.
Patient weight
Kg
Syringe label
Dose (mg)
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg
(150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1)
125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1)
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
40
60mg / 0.6ml
60 od
0.60
100mg/ml
45
80mg / 0.8ml
67.5 od
0.675
Solution for
50
80mg / 0.8ml
75 od
0.75
Injection
55
100mg
/
1ml
82.5
od
0.825
Clexane
60
100mg / 1ml
90 od
0.90
syringes
65
100mg / 1ml
97.5 od
0.975
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
70
120mg / 0.8ml
105 od
0.70
75
120mg / 0.8ml
112.5 od
0.76
150mg/ml
80
120mg / 0.8ml
120 od
0.80
Solution for
Injection
85
150mg / 1ml
127.5 od
0.86
Clexane
90
150mg / 1ml
135 od
0.90
Forte syringes
95
150mg / 1ml
142.5 od
0.96
100
150mg / 1ml
150 od
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection,
administered concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days
and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
40 bd
45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd
Injection
volume (ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
Injection
volume (ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
Dosage chart for 1mg/kg SC treatment of STEMI
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by
subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of
6 days and continued until the return to full ambulation, for a maximum of 14 days.
Patient weight
Injection
volume (ml)
0.70
0.74
0.78
0.80
0.84
0.88
0.90
0.94
0.98
1.00
Injection
volume (ml)
0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)
0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only,
followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific)
enoxaparin sodium should be given between 15 minutes before and 30 minutes after the
start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as
they are identified as having STEMI and maintained under (75 to 325mg once daily) unless
contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital
discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last
enoxaparin sodium SC administration was given less than 8 hours before balloon inflation,
no additional dosing is needed. If the last SC administration was given more than 8 hours
before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin sodium should be
administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of
a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as
after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may
be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5
mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular
access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75
years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12
hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the
remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney
function is impaired (see also section 4.2 Posology and method of administration: Renal
impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the
elderly; Renal impairment, and Monitoring; section 5.2 Pharmacokinetic properties).
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged >75 years only)
Adjusted
0.75mg/kg
dosing
Patient weight
Kg
Syringe label
Dose (mg)
(mg)
40
60mg / 0.6ml
30 bd
30 bd
45
60mg / 0.6ml
33.75 bd
35 bd
50
60mg / 0.6ml
37.5 bd
37.5 bd
55
60mg / 0.6ml
41.25 bd
42.5 bd
60
60mg / 0.6ml
45 bd
45 bd
65
60mg / 0.6ml
48.75 bd
50 bd
70
60mg / 0.6ml
52.5 bd
52.5 bd
75
60mg / 0.6ml
56.25 bd
57.5 bd
100mg/ml
80
60mg / 0.6ml
60 bd
60 bd
Solution for
Injection
85
80mg / 0.8ml
63.75 bd
65 bd
Clexane
90
80mg / 0.8ml
67.5 bd
67.5 bd
syringes
95
80mg / 0.8ml
71.25 bd
72.5 bd
100
80mg / 0.8ml
75 bd
75 bd
78.75 bd (1)
80 bd (1)
105
80mg / 0.8ml
82.5 bd (1)
82.5 bd (1)
110
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
115
100mg / 1ml
90 bd (1)
90 bd (1)
120
100mg / 1ml
93.75 bd (1)
95 bd (1)
125
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
130
100mg / 1ml
150mg/ml
101.25 bd (1)
102 bd (1)
135
120mg / 0.8ml
Solution for
105 bd (1)
105 bd (1)
140
120mg / 0.8ml
Injection
108.75 bd (1)
111 bd (1)
145
120mg / 0.8ml
Clexane Forte
112.5 bd (1)
114 bd (1)
150
120mg / 0.8ml
syringes
Injection
volume
(ml)
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
0.65
0.675
0.725
0.75
0.80 (1)
0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only,
followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal
impairment and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine
clearance < 30 ml/min), according to the following tables, since enoxaparin sodium
exposure is significantly increased in this patient population:
Dosage adjustments for therapeutic dosage range
Standard dosing
Severe renal impairment
1 mg/kg SC twice daily
1 mg/kg SC once daily
1.5 mg/kg SC once daily
1 mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC
30mg-single IV bolus plus a 1mg/kg SC
dose followed by 1mg/kg twice daily.
dose followed by 1mg/kg once daily.
(Max 100mg for each of the first two SC
(Max 100mg for first SC dose only)
doses)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial
bolus.
1mg/kg SC once daily without initial bolus.
(Max 75mg for each of the first two SC
(Max 100mg for first SC dose only)
doses)
Dosage adjustments for prophylactic dosage ranges
Standard dosing
40 mg SC once daily
20 mg SC once daily
Severe renal impairment
20 mg SC once daily
20 mg SC once daily
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80
or 100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The
30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8 hours
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional
IV bolus of 0.3mg/kg is to be administered if last SC administration was given more than 8
hours before balloon inflation (see section 4.2 Posology and method of administration:
Treatment of acute ST-segment Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to
dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is
recommended to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or
5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the
complete contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining
in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted
solution with a syringe for administration into the intravenous line (using an appropriate
injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following
formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table
below. It is recommended to prepare the dilution immediately before use and to discard any
remaining solution immediately after use.
Volume to be injected through intravenous line after dilution is completed
Weight
Required
dose
(0.3mg/kg)
(Kg)
45
50
55
60
65
70
75
80
85
90
95
(mg)
13.5
15
16.5
18
19.5
21
22.5
24
25.5
27
28.5
Volume to
inject when
diluted to
a final
concentration
of 3mg/ml
(ml)
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
Weight
Required
dose
(0.3mg/kg)
(kg)
100
105
110
115
120
125
130
135
140
145
150
(mg)
30
31.5
33
34.5
36
37.5
39
40.5
42
43.5
45
Volume to
inject when
diluted to a
final
concentration
of 3mg/ml
(ml)
10
10.5
11
11.5
12
12.5
13
13.5
14
14.5
15
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in
dextrose in water.
6.3 Shelf life
Do not use after the expiry date, which is stated on the carton. The expiry date refers to the
last day of that month.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Discard any unused product.
The recommended dosage adjustments do not apply to the haemodialysis indication.
6.5 Nature and contents of container
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal
impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine
clearance 50-80 ml/min), careful clinical monitoring is advised.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section
4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2
Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the prevention of venous
thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable
angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction
(STEMI); through the arterial line of a dialysis circuit for the prevention of thrombus formation
in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection
through an intravenous line only for the initial dose of acute STEMI indication and before PCI
when needed. It must not be administered by the intramuscular route.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be
administered when the patient is lying down by deep subcutaneous injection. The
administration should be alternated between the left and right anterolateral or posterolateral
abdominal wall. The whole length of the needle should be introduced vertically into a skin
fold held between the thumb and index finger. The skin fold should not be released until the
injection is complete.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes
can be used. Enoxaparin sodium should be administered through an intravenous line. It
should not be mixed or co-administered with other medications. To avoid the possible mixture
of enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed
with a sufficient amount of saline or dextrose solution prior to and following the intravenous
bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may
be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Leaflet revision and issue date (Ref.): 09.09.2013.
Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes).
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again
■ If you have any further questions, ask your doctor or pharmacist
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
■ If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger. This helps your body to break
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
■ Treat blood clots that are in your blood
■ Stop blood clots forming in your blood in the following situations:
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
■ After you have had a heart attack
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor, pharmacist or nurse if:
■
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■
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You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
or dalteparin
You have a problem with bruising or bleeding too easily
You have an ulcer in your stomach or gut (intestine)
You have had a stroke caused by bleeding in the brain
You have an infection in your heart
You are using the medicine called heparin to treat blood clots
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before using this medicine if:
■
■
■
■
■
■
■
■
■
■
■
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your eyes or brain
You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and especially if you are aged over 75 years old
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or
nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Clexane can affect the way some other medicines work. Also
some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
■ You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following medicines:
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming
■ Dextran injection - used as a blood replacer
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in
arthritis and other illnesses
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid
arthritis and other conditions
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane
Your doctor may change one of your medicines or take regular blood tests to check that
taking these medicines with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
have any problem with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as
you may be at increased risk of developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
3. How to use Clexane
Having this medicine
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Before you use Clexane your doctor or nurse may carry out a blood test
While you are in hospital your doctor or nurse will normally give you Clexane. This is
because it needs to be given as an injection
When you go home you may need to continue to use Clexane and give it to yourself
(see below instructions on how to do this)
Clexane is usually given by injection underneath the skin (subcutaneous)
If you are not sure why you are receiving Clexane or have any questions about how much
Clexane is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
■
■
Your doctor will decide how much to give you. The amount of Clexane given to you will
depend on the reason it is being used
If you have problems with your kidneys, you may be given a smaller amount of Clexane
1) Treating blood clots that are in your blood
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the following situations:
a) Unstable angina
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
b) After an operation or long periods of bedrest due to illness
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
are to develop a clot
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
each day. If you are going to have an operation, your first injection will usually be
given 2 hours before your operation
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
going to have an operation, your first injection will usually be given 12 hours before
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ At the same time, you will also be given Clexane as an injection under your skin
(subcutaneous injection). The usual dose is 1mg for every kilogram of your weight.
■ Then you will be given 1mg for every kilogram of your weight every 12 hours after
that
■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
If you are aged 75 years or older
■ Your doctor or nurse will give you injections of Clexane under your skin
(subcutaneous injection)
■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
■ The maximum amount of Clexane given for the first two injections is 75mg
For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ Depending on when you were last given Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
3) Stop blood clots forming in the tubes of your dialysis machine
■ The usual dose is 1 mg for every kilogram of your weight
■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
session
■ This amount is usually enough for a 4 hour session. However, your doctor may give
you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not been trained how to do so. If you are not
sure what to do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
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Check the expiry date on the medicine. Do not use if the date has passed
Check the syringe is not damaged and the medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are going to inject
Check your abdomen to see if the last injection caused any redness, change in skin
colour, swelling, oozing or is still painful, if so talk to your doctor or nurse
Decide where you are going to inject the medicine. Change the place where you inject
each time from the right to the left side of your stomach. Clexane should be injected just
under the skin on your stomach, but not too near the belly button or any scar tissue (at
least 5 cm away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with soap and water. Dry them.
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
Blood Tests
Using Clexane may affect the results of some blood tests. If you are going to have a blood
test, it is important to tell your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away if you notice any of the
following side-effects:
Very common (affects more than 1 in 10 people)
■ Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
■ A painful rash of dark red spots under the skin which do not go away when you put
pressure on them. You may also notice pink patches on your skin. These are more likely
to appear in the area you have been injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
■ Sudden severe headache. This could be a sign of bleeding in the brain.
■ A feeling of tenderness and swelling in your stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
■ If you have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
■ If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the lower part of your body. Also if you lose
control over your bladder or bowel (so you cannot control when you go to the toilet).
3) Choose an area on the right or left side of your stomach. This should be at least 5
centimetres away from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres of your belly button or around
existing scars or bruises. Change the place where you inject between the left and right
sides of your stomach, depending on the area you were last injected.
4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch
anything. This is to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and with your other hand,
gently pinch the cleaned area of your abdomen between your forefinger and thumb to
make a fold in the skin.
Tell a nurse or doctor as soon as possible if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
(thrombocytopenia).
■ You have pain, swelling or irritation in the area you have been injected with Clexane.
This normally gets better after a few days.
Rare (affects less than 1 in a 1000 people)
■ If you have a mechanical heart valve, treatment with Clexane might not be sufficient to
prevent blood clots. You may notice that you have difficulty breathing, tiredness or
difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This
could be due to a blood clot on the heart valve
Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Very common (affects more than 1 in 10 people)
■ Changes in the results of blood tests done to check how your liver is working. These
usually go back to normal after you stop having Clexane.
Rare (affects less than 1 in a 1000 people)
■ Changes in the potassium levels in your blood. This is more likely to happen in people
with kidney problems or diabetes. Your doctor will be able to check this by carrying out a
blood test.
Frequency unknown
■ If Clexane is used for a long period of time, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break
Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Insert the full length of the needle into the skin fold.
7) Press down on the plunger with your finger.
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date, which is stated on the carton.
Do not store above 25°C. Do not refrigerate or freeze.
If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. If you are using
this medicine at home you will be given a container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to protect the environment.
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8) Remove the needle by pulling it straight out.
You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself.
6. Further Information
9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the
container lid tightly and place the container out of reach of children.
When the container is full, give it to your doctor or home care nurse for disposal.
Do not put it in the household rubbish.
■
If you have more Clexane than you should
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no signs of a problem. If a child accidentally
injects or swallows Clexane, take them to a hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as you remember. Do not give
yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary
will help to make sure you do not miss a dose.
If you stop using Clexane
It is important for you to keep having Clexane injections until your doctor decides to stop
them. If you stop, you could get a blood clot which can be very dangerous.
What Clexane contains
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Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.4ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 1ml
The other ingredient is water for injections
active
active
active
active
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
POM
PL No: 15814/1002
The Manufacturer is Sanofi Winthrop Industrie, Boulevard Industrial, Le Trait, F-76580
France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet revision and issue date (Ref.) 09.09.2013.
The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
PACKAGE LEAFLET: INFORMATION FOR THE USER
Clexane® 20mg/0.2ml Syringes/ Clexane® 40mg/0.4ml Syringes/
Clexane® 80mg/0.8ml Syringes/ Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
This product is available as any of the above names but will be referred to as Clexane
throughout the following leaflet. Please note that the leaflet also contains information
about another strength (Clexane 60mg/0.6ml Syringes).
Read all of this leaflet carefully before you start using this medicine
■ Keep this leaflet. You may need to read it again
■ If you have any further questions, ask your doctor or pharmacist
■ This medicine has been prescribed for you. Do not pass it on to others. It may harm
them, even if their symptoms are the same as yours
■ If any of the side effects get serious, or if you notice any side effects not listed in this
leaflet, please tell your doctor or pharmacist
In this leaflet:
1. What Clexane is and what it is used for
2. Before you use Clexane
3. How to use Clexane
4. Possible side-effects
5. How to store Clexane
6. Further information
1. What Clexane is and what it is used for
Clexane contains a medicine called enoxaparin sodium. This belongs to a group of
medicines called Low Molecular Weight Heparins.
Clexane works in two ways.
1) Stopping existing blood clots from getting any bigger. This helps your body to break
them down and stop them causing you harm.
2) Stopping blood clots forming in your blood.
Clexane can be used to:
■ Treat blood clots that are in your blood
■ Stop blood clots forming in your blood in the following situations:
■ Unstable angina (where not enough blood gets to your heart)
■ After an operation or long periods of bed rest due to illness
■ After you have had a heart attack
■ Stop blood clots forming in the tubes of your dialysis machine (used for people with
kidney problems)
2. Before you use Clexane
Do not have this medicine and tell your doctor, pharmacist or nurse if:
■
■
■
■
■
■
■
You are allergic (hypersensitive) to enoxaparin sodium or any of the other ingredients of
Clexane (listed in Section 6: Further information).
Signs of an allergic reaction include: a rash, swallowing or breathing problems, swelling
of your lips, face, throat or tongue
You are allergic to heparin or other Low Molecular Weight Heparins such as tinzaparin
or dalteparin
You have a problem with bruising or bleeding too easily
You have an ulcer in your stomach or gut (intestine)
You have had a stroke caused by bleeding in the brain
You have an infection in your heart
You are using the medicine called heparin to treat blood clots
Do not have this medicine if any of the above apply to you. If you are not sure, talk to your
doctor, pharmacist or nurse before having Clexane.
Take special care with Clexane
Check with your doctor or pharmacist or nurse before using this medicine if:
■
■
■
■
■
■
■
■
■
■
■
You have high blood pressure
You have kidney problems
You have had a heart valve fitted
You have ever had bruising and bleeding caused by the medicine ‘heparin’
You have ever had a stroke
You have ever had a stomach ulcer
You have recently had an operation on your eyes or brain
You are a diabetic or have a illness known as ‘diabetic retinopathy’ (problems with the
blood vessels in the eye caused by diabetes)
You have any problems with your blood
You are underweight or overweight
You are elderly (over 65 years old) and especially if you are aged over 75 years old
If you are not sure if any of the above applies to you, talk to your doctor or pharmacist or
nurse before using Clexane.
Taking or using other medicines
Please tell your doctor, pharmacist or nurse if you are taking or have recently taken any
other medicines. This includes medicines you buy without a prescription, including herbal
medicines. This is because Clexane can affect the way some other medicines work. Also
some medicines can affect the way Clexane works.
In particular, do not have this medicine and tell your doctor if:
■ You are using the medicine called heparin to treat blood clots
Tell your doctor if you are taking any of the following medicines:
■ Warfarin - used for thinning the blood
■ Aspirin, dipyridamole, clopidogrel or other medicines - used to stop blood clots forming
■ Dextran injection - used as a blood replacer
■ Ibuprofen, diclofenac, ketorolac or other medicines - used to treat pain and swelling in
arthritis and other illnesses
■ Prednisolone, dexamethasone or other medicines - used to treat asthma, rheumatoid
arthritis and other conditions
■ Water tablets (diuretics) such as spironolactone, triamterene or amiloride. These may
increase the levels of potassium in your blood when taken with Clexane
Your doctor may change one of your medicines or take regular blood tests to check that
taking these medicines with Clexane is not causing you any harm.
Operations and anaesthetics
If you are going to have a spinal puncture or an operation where an epidural or spinal
anaesthetic is used, tell your doctor that you are using Clexane. Tell also your doctor if you
have any problem with your spine or if you have ever had spinal surgery.
Pregnancy and breast-feeding
Talk to your doctor before you use this medicine if you are pregnant, might become
pregnant, or think you may be pregnant.
You should not use this medicine if you are pregnant and have a mechanical heart valve as
you may be at increased risk of developing blood clots. Your doctor should discuss this with
you.
You should not breast-feed whilst using Clexane. If you are planning to breast-feed, talk to
your doctor, pharmacist or nurse.
Ask your doctor or pharmacist for advice before taking any medicine if you are pregnant or
breast-feeding.
3. How to use Clexane
Having this medicine
■
■
■
■
Before you use Clexane your doctor or nurse may carry out a blood test
While you are in hospital your doctor or nurse will normally give you Clexane. This is
because it needs to be given as an injection
When you go home you may need to continue to use Clexane and give it to yourself
(see below instructions on how to do this)
Clexane is usually given by injection underneath the skin (subcutaneous)
If you are not sure why you are receiving Clexane or have any questions about how much
Clexane is being given to you, speak to your doctor, pharmacist or nurse.
How much will be given to you
■
■
Your doctor will decide how much to give you. The amount of Clexane given to you will
depend on the reason it is being used
If you have problems with your kidneys, you may be given a smaller amount of Clexane
1) Treating blood clots that are in your blood
■ The usual dose is 1.5mg for every kilogram of your weight, each day
■ Clexane will usually be given for at least 5 days
2) Stopping blood clots forming in your blood in the following situations:
a) Unstable angina
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
b) After an operation or long periods of bedrest due to illness
The usual dose is 20mg or 40mg each day. The dose will depend on how likely you
are to develop a clot
■ If you have a low to medium risk of getting a clot, you will be given 20mg of Clexane
each day. If you are going to have an operation, your first injection will usually be
given 2 hours before your operation
■ If you have a higher risk of getting a clot, you will be given 40mg each day. If you are
going to have an operation, your first injection will usually be given 12 hours before
your operation
■ If you are bedridden due to illness, you will be normally be given 40mg of Clexane
each day for 6 to 14 days
c) After you have had a heart attack
Clexane can be used for two different types of heart attack called NSTEMI or STEMI.
The amount of Clexane given to you will depend on your age and the kind of heart
attack you have had.
i) NSTEMI type of heart attack
■ The usual amount is 1mg for every kilogram of weight, every 12 hours
■ Clexane will usually be given for 2 to 8 days. Your doctor will normally ask you to take
aspirin as well
ii) STEMI type of heart attack
If you are under 75 years old
■ 30mg of Clexane will be given as an injection into your vein (intravenous injection
using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
■ At the same time, you will also be given Clexane as an injection under your skin
(subcutaneous injection). The usual dose is 1mg for every kilogram of your weight.
■ Then you will be given 1mg for every kilogram of your weight every 12 hours after
that
■ The maximum amount of Clexane given for the first two injections is 100mg
■ The injections will normally be given for up to 8 days
If you are aged 75 years or older
■ Your doctor or nurse will give you injections of Clexane under your skin
(subcutaneous injection)
■ The usual dose is 0.75mg for every kilogram of your weight, every 12 hours
■ The maximum amount of Clexane given for the first two injections is 75mg
For patients having an operation called Percutaneous Coronary Intervention (PCI)
■ Depending on when you were last given Clexane, your doctor may decide to give an
additional dose of Clexane before a PCI operation. This is by injection into your vein
(intravenous using Clexane Multidose Vial or 60, 80 or 100mg Pre-filled syringes)
3) Stop blood clots forming in the tubes of your dialysis machine
■ The usual dose is 1 mg for every kilogram of your weight
■ Clexane is added to the tube leaving the body (arterial line) at the start of the dialysis
session
■ This amount is usually enough for a 4 hour session. However, your doctor may give
you a further dose of 0.5 to 1mg for every kilogram of your weight if necessary
How to give yourself an injection of Clexane
If you are able to give Clexane to yourself, your doctor or nurse will show you how to do
this. Do not try to inject yourself if you have not been trained how to do so. If you are not
sure what to do, talk to your doctor or nurse immediately.
Before injecting yourself with Clexane
■
■
■
■
■
Check the expiry date on the medicine. Do not use if the date has passed
Check the syringe is not damaged and the medicine in it is a clear solution. If not, use
another syringe
Make sure you know how much you are going to inject
Check your abdomen to see if the last injection caused any redness, change in skin
colour, swelling, oozing or is still painful, if so talk to your doctor or nurse
Decide where you are going to inject the medicine. Change the place where you inject
each time from the right to the left side of your stomach. Clexane should be injected just
under the skin on your stomach, but not too near the belly button or any scar tissue (at
least 5 cm away from these)
Instructions on injecting yourself with Clexane:
1) Wash your hands and the area that you will inject with soap and water. Dry them.
2) Sit or lie in a comfortable position so you are relaxed. Make sure you can see the place
you are going to inject. A lounge chair, recliner, or bed propped up with pillows is ideal.
Blood Tests
Using Clexane may affect the results of some blood tests. If you are going to have a blood
test, it is important to tell your doctor you are having Clexane.
4. Possible side-effects
Like all medicines, Clexane can cause side-effects, although not everybody gets them.
Tell a nurse or doctor or go to hospital straight away if you notice any of the
following side-effects:
Very common (affects more than 1 in 10 people)
■ Bleeding a lot from a wound.
Common (affects 1 to 10 people in a 100)
■ A painful rash of dark red spots under the skin which do not go away when you put
pressure on them. You may also notice pink patches on your skin. These are more likely
to appear in the area you have been injected with Clexane.
Uncommon (affects 1 to 10 people in a 1,000)
■ Sudden severe headache. This could be a sign of bleeding in the brain.
■ A feeling of tenderness and swelling in your stomach. You may have bleeding inside
your stomach.
Rare (affects less than 1 in a 1000 people)
■ If you have an allergic reaction. The signs may include: a rash, swallowing or breathing
problems, swelling of your lips, face, throat or tongue.
■ If you have had a spinal puncture or a spinal anaesthetic and notice tingling, numbness
and muscular weakness, particularly in the lower part of your body. Also if you lose
control over your bladder or bowel (so you cannot control when you go to the toilet).
3) Choose an area on the right or left side of your stomach. This should be at least 5
centimetres away from your belly button and out towards your sides.
Remember: Do not inject yourself within 5 centimetres of your belly button or around
existing scars or bruises. Change the place where you inject between the left and right
sides of your stomach, depending on the area you were last injected.
4) Carefully pull off the needle cap from the Clexane syringe. Throw away the cap. The
syringe is pre-filled and ready to use.
Do not press on the plunger before injecting yourself to get rid of air bubbles. This can lead
to a loss of the medicine. Once you have removed the cap, do not allow the needle to touch
anything. This is to make sure the needle stays clean (sterile).
5) Hold the syringe in the hand you write with (like a pencil) and with your other hand,
gently pinch the cleaned area of your abdomen between your forefinger and thumb to
make a fold in the skin.
Tell a nurse or doctor as soon as possible if you notice any of the following side
effects:
Common (affects 1 to 10 people in a 100)
■ You bruise more easily than usual. This could be because of a blood problem
(thrombocytopenia).
■ You have pain, swelling or irritation in the area you have been injected with Clexane.
This normally gets better after a few days.
Rare (affects less than 1 in a 1000 people)
■ If you have a mechanical heart valve, treatment with Clexane might not be sufficient to
prevent blood clots. You may notice that you have difficulty breathing, tiredness or
difficulty exercising, chest pain, numbness, feeling sick or loss of consciousness. This
could be due to a blood clot on the heart valve
Other side effects that you should discuss with your nurse or doctor if you are
concerned about them:
Very common (affects more than 1 in 10 people)
■ Changes in the results of blood tests done to check how your liver is working. These
usually go back to normal after you stop having Clexane.
Rare (affects less than 1 in a 1000 people)
■ Changes in the potassium levels in your blood. This is more likely to happen in people
with kidney problems or diabetes. Your doctor will be able to check this by carrying out a
blood test.
Frequency unknown
■ If Clexane is used for a long period of time, it may increase the risk of you getting a
condition called ‘osteoporosis’. This is when your bones are more likely to break
Make sure you hold the skin fold throughout the injection.
6) Hold the syringe so that the needle is pointing downwards (vertically at a 90º angle).
Insert the full length of the needle into the skin fold.
7) Press down on the plunger with your finger.
This will send the medication into the fatty tissue of the stomach. Make sure you hold the
skin fold throughout the injection.
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any
possible side effects not listed in this leaflet. You can also report side effects directly via the
Yellow Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more information on the safety of this
medicine.
5. How to store and dispose of Clexane
Keep out of the sight and reach of children.
Do not use Clexane after the expiry date, which is stated on the carton.
Do not store above 25°C. Do not refrigerate or freeze.
If this medicine becomes discoloured or show signs of any deterioration, you should
seek the advice of your pharmacist.
Medicines should not be disposed of via wastewater or household waste. If you are using
this medicine at home you will be given a container (a sharps bin) to use for disposal.
Return the sharps bin or any used or unused syringes to your doctor or nurse or pharmacist
for disposal. These measures will help to protect the environment.
■
■
■
■
8) Remove the needle by pulling it straight out.
You can now let go of the skin fold.
To avoid bruising, do not rub the injection site after you have injected yourself.
6. Further Information
9) Drop the used syringe - the needle end first - into the sharps bin provided. Close the
container lid tightly and place the container out of reach of children.
When the container is full, give it to your doctor or home care nurse for disposal.
Do not put it in the household rubbish.
■
If you have more Clexane than you should
If you think that you have used too much or too little Clexane, tell your doctor, nurse or
pharmacist immediately, even if you have no signs of a problem. If a child accidentally
injects or swallows Clexane, take them to a hospital casualty department straight away.
If you forget to use Clexane
If you forget to give yourself a dose, have it as soon as you remember. Do not give
yourself a double dose on the same day to make up for a forgotten dose. Keeping a diary
will help to make sure you do not miss a dose.
If you stop using Clexane
It is important for you to keep having Clexane injections until your doctor decides to stop
them. If you stop, you could get a blood clot which can be very dangerous.
What Clexane contains
■
■
■
■
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.4ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10,000 IU anti-Xa activity) of the
substance, enoxaparin sodium, in 1ml
The other ingredient is water for injections
active
active
active
active
What Clexane Syringes looks like and contents of the pack
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s
POM
PL No: 15814/1002
The Manufacturer is Aventis Pharma Le Trait, Boulevard Industrial, Le Trait, F-76580
France and procured from within the EU by the Product Licence Holder and repackaged by
OPD Laboratories Limited, Colonial Way, Watford, Herts WD24 4PR.
This leaflet does not contain all the information about your medicine. If you have any
questions or are not sure about anything, ask your doctor or pharmacist.
Leaflet revision and issue date (Ref.) 09.09.2013.
The registered Trademark holder for Clexane is Sanofi-Aventis.
To request a copy of this leaflet in Braille, large print or audio please call 01923 332 796.
THE FOLLOWING INFORMATION IS INTENDED FOR HEALTHCARE
PROFESSIONALS ONLY
®
®
Clexane 20mg/0.2ml Syringes/ Clexane 40mg/0.4ml Syringes
Clexane® 60mg/0.6ml Syringes/ Clexane® 80mg/0.8ml Syringes
Clexane® 100mg/1ml Syringes
(enoxaparin sodium)
The following information is extracted from the SPC
Technical information for the administration of Clexane Syringes
1. NAME OF THE MEDICINAL PRODUCT
This product is available using any of the above names but will be referred to as Clexane
throughout the following leaflet.
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Pre-filled syringes:
Each 20mg pre-filled syringe contains 20mg (2000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.2ml
Each 40mg pre-filled syringe contains 40mg (4000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.4ml
Each 60mg pre-filled syringe contains 60mg (6000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.6ml
Each 80mg pre-filled syringe contains 80mg (8000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 0.8ml
Each 100mg pre-filled syringe contains 100mg (10000 IU anti-Xa activity) of
substance, enoxaparin sodium, in 1ml
the active
the active
the active
the active
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Patient weight
Kg
Syringe label
Dose (mg)
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
120mg / 0.8ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
150mg / 1ml
105 bd
110 bd
115 bd
120 bd
125 bd
130 bd
135 bd
140 bd
145 bd
150 bd
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Treatment of acute ST-segment Elevation Myocardial Infarction
The recommended dose of enoxaparin sodium is a single IV bolus of 30mg plus a 1mg/kg
SC dose followed by 1mg/kg administered SC every 12 hours (max 100mg for the first two
doses only, followed by 1mg/kg dosing for the remaining doses). For dosage in patients
≥75 years of age, see section 4.2 Posology and method of administration: Elderly.
the active
For full list of excipients, see section 6.1
Dosage chart for 1mg/kg SC treatment of STEMI
Patient weight
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
40 bd
45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd
3. PHARMACEUTICAL FORM
Solution for injection.
Clear, colourless solution.
4.2 Posology and method of administration
Adults:
Prophylaxis of venous thromboembolism:
In patients with a low to moderate risk of venous thromboembolism the recommended
dosage is 20 mg (2,000 IU) once daily by subcutaneous injection for 7 to 10 days, or until the
risk of thromboembolism has diminished. In patients undergoing surgery, the initial dose
should be given approximately 2 hours pre-operatively. In patients with a higher risk, such as
in orthopaedic surgery, the dosage should be 40 mg (4,000 IU) daily by subcutaneous
injection with the initial dose administered approximately 12 hours before surgery.
Patient weight
Kg
Syringe label
Dose (mg)
Treatment of venous thromboembolism:
Clexane should be administered subcutaneously as a single daily injection of 1.5 mg/kg
(150 IU/kg). Clexane treatment is usually prescribed for at least 5 days and until adequate
oral anticoagulation is established.
150mg/ml
Solution for
Injection
Clexane
Forte syringes
105
110
115
120
125
130
135
140
145
150
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
120mg / 0.8ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
150mg / 1ml (1)
105 bd (1)
110 bd (1)
115 bd (1)
120 bd (1)
125 bd (1)
130 bd (1)
135 bd (1)
140 bd (1)
145 bd (1)
150 bd (1)
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
40
60mg / 0.6ml
60 od
0.60
100mg/ml
45
80mg / 0.8ml
67.5 od
0.675
Solution for
50
80mg / 0.8ml
75 od
0.75
Injection
55
100mg
/
1ml
82.5
od
0.825
Clexane
60
100mg / 1ml
90 od
0.90
syringes
65
100mg / 1ml
97.5 od
0.975
Dosage chart for 1.5mg/kg SC treatment of DVT, PE or both
Injection
Patient weight
Kg
Syringe label
Dose (mg)
volume (ml)
70
120mg / 0.8ml
105 od
0.70
75
120mg / 0.8ml
112.5 od
0.76
150mg/ml
80
120mg / 0.8ml
120 od
0.80
Solution for
Injection
85
150mg / 1ml
127.5 od
0.86
Clexane
90
150mg / 1ml
135 od
0.90
Forte syringes
95
150mg / 1ml
142.5 od
0.96
100
150mg / 1ml
150 od
1.00
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Treatment of unstable angina and non-Q-wave myocardial infarction
The recommended dose is 1 mg/kg Clexane every 12 hours by subcutaneous injection,
administered concurrently with oral aspirin (100 to 325mg once daily).
Treatment with Clexane in these patients should be prescribed for a minimum of 2 days
and continued until clinical stabilisation. The usual duration of treatment is 2 to 8 days.
Dosage chart for 1mg/kg SC treatment of UA or NSTEMI
Kg
Syringe label
Dose (mg)
100mg/ml
Solution for
Injection
Clexane
syringes
40
45
50
55
60
65
70
75
80
85
90
95
100
40mg / 0.4ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
60mg / 0.6ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
80mg / 0.8ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
100mg / 1ml
40 bd
45 bd
50 bd
55 bd
60 bd
65 bd
70 bd
75 bd
80 bd
85 bd
90 bd
95 bd
100 bd
Injection
volume (ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
Injection
volume (ml)
0.40
0.45
0.50
0.55
0.60
0.65
0.70
0.75
0.80
0.85
0.90
0.95
1.00
Dosage chart for 1mg/kg SC treatment of STEMI
Prophylaxis of venous thromboembolism in medical patients:
The recommended dose of enoxaparin sodium is 40 mg (4,000 IU) once daily by
subcutaneous injection. Treatment with enoxaparin sodium is prescribed for a minimum of
6 days and continued until the return to full ambulation, for a maximum of 14 days.
Patient weight
Injection
volume (ml)
0.70
0.74
0.78
0.80
0.84
0.88
0.90
0.94
0.98
1.00
Injection
volume (ml)
0.70 (1)
0.74 (1)
0.78 (1)
0.80 (1)
0.84 (1)
0.88 (1)
0.90 (1)
0.94 (1)
0.98 (1)
1.00 (1)
(1) Not to be given for the first two doses - (maximum 100mg for the first two doses only,
followed by 1mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
When administered in conjunction with a thrombolytic (fibrin specific or non-fibrin specific)
enoxaparin sodium should be given between 15 minutes before and 30 minutes after the
start of fibrinolytic therapy. All patients should receive acetylsalicylic acid (ASA) as soon as
they are identified as having STEMI and maintained under (75 to 325mg once daily) unless
contraindicated.
The recommended duration of enoxaparin sodium treatment is 8 days or until hospital
discharge, whichever comes first.
For patients managed with Percutaneous Coronary Intervention (PCI): If the last
enoxaparin sodium SC administration was given less than 8 hours before balloon inflation,
no additional dosing is needed. If the last SC administration was given more than 8 hours
before balloon inflation, an IV bolus of 0.3mg/kg of enoxaparin sodium should be
administered.
Prevention of extracorporeal thrombus formation during haemodialysis:
A dose equivalent to 1 mg/kg (100 IU/kg) introduced into the arterial line at the beginning of
a dialysis session is usually sufficient for a 4 hour session. If fibrin rings are found, such as
after a longer than normal session, a further dose of 0.5 to 1mg/kg (50 to 100 IU/kg) may
be given. For patients at a high risk of haemorrhage the dose should be reduced to 0.5
mg/kg (50 IU/kg) for double vascular access or 0.75 mg/kg (75 IU/kg) for single vascular
access.
Elderly:
For treatment of acute ST-segment Elevation Myocardial Infarction in elderly patients ≥75
years of age, do not use an initial IV bolus. Initiate dosing with 0.75mg/kg SC every 12
hours (maximum 75mg for the first two doses only, followed by 0.75mg/kg dosing for the
remaining doses).
For other indications, no dosage adjustments are necessary in the elderly, unless kidney
function is impaired (see also section 4.2 Posology and method of administration: Renal
impairment; section 4.4 Special warnings and precautions for use: Haemorrhage in the
elderly; Renal impairment, and Monitoring; section 5.2 Pharmacokinetic properties).
Dosage chart for 0.75mg/kg SC treatment of STEMI
(elderly patients aged >75 years only)
Adjusted
0.75mg/kg
dosing
Patient weight
Kg
Syringe label
Dose (mg)
(mg)
40
60mg / 0.6ml
30 bd
30 bd
45
60mg / 0.6ml
33.75 bd
35 bd
50
60mg / 0.6ml
37.5 bd
37.5 bd
55
60mg / 0.6ml
41.25 bd
42.5 bd
60
60mg / 0.6ml
45 bd
45 bd
65
60mg / 0.6ml
48.75 bd
50 bd
70
60mg / 0.6ml
52.5 bd
52.5 bd
75
60mg / 0.6ml
56.25 bd
57.5 bd
100mg/ml
80
60mg / 0.6ml
60 bd
60 bd
Solution for
Injection
85
80mg / 0.8ml
63.75 bd
65 bd
Clexane
90
80mg / 0.8ml
67.5 bd
67.5 bd
syringes
95
80mg / 0.8ml
71.25 bd
72.5 bd
100
80mg / 0.8ml
75 bd
75 bd
78.75 bd (1)
80 bd (1)
105
80mg / 0.8ml
82.5 bd (1)
82.5 bd (1)
110
100mg / 1ml
86.25 bd (1)
87.5 bd (1)
115
100mg / 1ml
90 bd (1)
90 bd (1)
120
100mg / 1ml
93.75 bd (1)
95 bd (1)
125
100mg / 1ml
97.5 bd (1)
97.5 bd (1)
130
100mg / 1ml
150mg/ml
101.25 bd (1)
102 bd (1)
135
120mg / 0.8ml
Solution for
105 bd (1)
105 bd (1)
140
120mg / 0.8ml
Injection
108.75 bd (1)
111 bd (1)
145
120mg / 0.8ml
Clexane Forte
112.5 bd (1)
114 bd (1)
150
120mg / 0.8ml
syringes
Injection
volume
(ml)
0.30
0.35
0.375
0.425
0.45
0.5
0.525
0.575
0.60
0.65
0.675
0.725
0.75
0.80 (1)
0.825 (1)
0.875 (1)
0.90 (1)
0.95 (1)
0.975 (1)
0.68 (1)
0.7 (1)
0.74 (1)
0.76 (1)
(1) not to be given for the first two doses - (maximum 75mg for the first two doses only,
followed by 0.75mg/kg dosing for the remaining doses)
Please be aware that in some cases it is not possible to achieve an exact dose due to the
graduations on the syringe and so some of the volumes recommended in this table have
been rounded up to the nearest graduation.
Children: Not recommended, as dosage not established.
Renal impairment: (See also section 4.4 Special warnings and precautions for use: Renal
impairment and Monitoring; section 5.2 Pharmacokinetic properties).
Severe renal impairment:
A dosage adjustment is required for patients with severe renal impairment (creatinine
clearance < 30 ml/min), according to the following tables, since enoxaparin sodium
exposure is significantly increased in this patient population:
Dosage adjustments for therapeutic dosage range
Standard dosing
Severe renal impairment
1 mg/kg SC twice daily
1 mg/kg SC once daily
1.5 mg/kg SC once daily
1 mg/kg SC once daily
For treatment of acute STEMI in patients <75 years of age
30mg-single IV bolus plus a 1mg/kg SC
30mg-single IV bolus plus a 1mg/kg SC
dose followed by 1mg/kg twice daily.
dose followed by 1mg/kg once daily.
(Max 100mg for each of the first two SC
(Max 100mg for first SC dose only)
doses)
For treatment of acute STEMI in elderly patients ≥75 years of age
0.75mg/kg SC twice daily without initial
bolus.
1mg/kg SC once daily without initial bolus.
(Max 75mg for each of the first two SC
(Max 100mg for first SC dose only)
doses)
Dosage adjustments for prophylactic dosage ranges
Standard dosing
40 mg SC once daily
20 mg SC once daily
Severe renal impairment
20 mg SC once daily
20 mg SC once daily
• Initial 30mg bolus
For the initial 30mg bolus, using an enoxaparin sodium graduated prefilled syringe (60, 80
or 100mg), expel the excessive volume to retain only 30mg (0.3ml) in the syringe. The
30mg dose can then be directly injected into an injection site in the intravenous line.
• Additional bolus for PCI when last SC administration was given more than 8 hours
before balloon insertion
For patients being managed with Percutaneous Coronary Intervention (PCI), an additional
IV bolus of 0.3mg/kg is to be administered if last SC administration was given more than 8
hours before balloon inflation (see section 4.2 Posology and method of administration:
Treatment of acute ST-segment Elevation Myocardial Infarction).
In order to assure the accuracy of the small volume to be injected, it is recommended to
dilute the drug to 3mg/ml.
To obtain a 3mg/ml solution, using a 60mg enoxaparin sodium prefilled syringe, it is
recommended to use a 50ml infusion bag (i.e. using either normal saline solution (0.9%) or
5% dextrose in water) as follows:
Withdraw 30ml from the infusion bag with a syringe and discard the liquid. Inject the
complete contents of the 60mg enoxaparin sodium prefilled syringe into the 20ml remaining
in the bag. Gently mix the contents of the bag. Withdraw the required volume of diluted
solution with a syringe for administration into the intravenous line (using an appropriate
injection site or port).
After dilution is completed, the volume to be injected can be calculated using the following
formula [Volume of diluted solution (ml) = Patient weight (kg) x 0.1] or using the table
below. It is recommended to prepare the dilution immediately before use and to discard any
remaining solution immediately after use.
Volume to be injected through intravenous line after dilution is completed
Weight
Required
dose
(0.3mg/kg)
(Kg)
45
50
55
60
65
70
75
80
85
90
95
(mg)
13.5
15
16.5
18
19.5
21
22.5
24
25.5
27
28.5
Volume to
inject when
diluted to
a final
concentration
of 3mg/ml
(ml)
4.5
5
5.5
6
6.5
7
7.5
8
8.5
9
9.5
Weight
Required
dose
(0.3mg/kg)
(kg)
100
105
110
115
120
125
130
135
140
145
150
(mg)
30
31.5
33
34.5
36
37.5
39
40.5
42
43.5
45
Volume to
inject when
diluted to a
final
concentration
of 3mg/ml
(ml)
10
10.5
11
11.5
12
12.5
13
13.5
14
14.5
15
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Water for Injections
6.2 Incompatibilities
Subcutaneous Injection
Clexane should not be mixed with any other injections or infusions.
Intravenous (Bolus) Injection for acute STEMI indication only
Enoxaparin sodium may be safely administered with normal saline solution (0.9%) or 5% in
dextrose in water.
6.3 Shelf life
Do not use after the expiry date, which is stated on the carton. The expiry date refers to the
last day of that month.
6.4 Special precautions for storage
Do not store above 25°C. Do not refrigerate or freeze. Discard any unused product.
The recommended dosage adjustments do not apply to the haemodialysis indication.
6.5 Nature and contents of container
Clexane is a clear solution in a Type I glass pre-filled syringe fitted with an injection needle
and needle cap. Clexane is available in packs of 6 and 10’s.
Moderate and mild renal impairment:
Although no dosage adjustments are recommended in patients with moderate renal
impairment (creatinine clearance 30-50 ml/min) or mild renal impairment (creatinine
clearance 50-80 ml/min), careful clinical monitoring is advised.
6.6 Special precautions for disposal
See section 4.2 Posology and method of administration.
Hepatic impairment: In the absence of clinical studies, caution should be exercised.
Body weight:
No dosage adjustments are recommended in obesity or low body weight (see also section
4.4 Special warnings and precautions for use: Low body weight and Monitoring; section 5.2
Pharmacokinetic properties).
Clexane is administered by subcutaneous injection for the prevention of venous
thromboembolic disease, treatment of deep vein thrombosis or for the treatment of unstable
angina, non-Q-wave myocardial infarction and acute ST elevation myocardial infarction
(STEMI); through the arterial line of a dialysis circuit for the prevention of thrombus formation
in the extra-corporeal circulation during haemodialysis; and via intravenous (bolus) injection
through an intravenous line only for the initial dose of acute STEMI indication and before PCI
when needed. It must not be administered by the intramuscular route.
Subcutaneous injection technique
The prefilled disposable syringe is ready for immediate use. Clexane should be
administered when the patient is lying down by deep subcutaneous injection. The
administration should be alternated between the left and right anterolateral or posterolateral
abdominal wall. The whole length of the needle should be introduced vertically into a skin
fold held between the thumb and index finger. The skin fold should not be released until the
injection is complete.
Do not rub the injection site after administration.
Intravenous (Bolus) Injection Technique (for acute STEMI indication only):
For intravenous injection, either the Multidose Vial or 60mg, 80mg or 100mg prefilled syringes
can be used. Enoxaparin sodium should be administered through an intravenous line. It
should not be mixed or co-administered with other medications. To avoid the possible mixture
of enoxaparin sodium with all other drugs, the intravenous access chosen should be flushed
with a sufficient amount of saline or dextrose solution prior to and following the intravenous
bolus administration of enoxaparin sodium to clear the port of drug. Enoxaparin sodium may
be safely administered with normal saline solution (0.9%) or 5% dextrose in water.
Leaflet revision and issue date (Ref.): 09.09.2013.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
